A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (<=2cm)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006654

Enrollment

Unknown

Registered

2015-06-26

Start date

2015-07-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

Experimental:segmentectomy

Active Comparator:lobectomy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70y; 2. Preoperative criteria: (1) Center of tumor is located in the outer third of the lung field, and the maximal diameter <=2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan; (2) no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS; 3. Intraoperative criteria: (1) Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section; (2) Lobectomy, single segmentectomy or combined segmentectomy is feasible; (3) Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy. 4. ECOG performance status 0-2; 5. No other malignancy within the past 3 years (except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix); 6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed); 7. No prior chemotherapy or radiation therapy; 8. Lobectomy is tolerated; 9. Sufficient organ functions; 10. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Active bacterial or fungous infection; 2. Simultaneous or metachronous (within the past 5 years) multiple cancers; 3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy; 4. Psychosis; 5. Uncontrollable diabetes mellitus; 6. History of severe heart disease; 7. The maximal diameter of GGO<=5mm; 8. N1, N2, or M1a is confirmed postoperatively; 9. Postoperative adjuvant therapy (chemotherapy, radiotherapy or targeted therapy); 10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.; 11. Confirmation of benign disease by postoperative pathologic examination; 12. Lesion located in the middle lobe.

Design outcomes

Primary

Measure	Time frame
Relapse-free survival;	—

Secondary

Measure	Time frame
Overall survival;Pulmonary function;The duration of postoperative hospital stay;Performance status;	—

Countries

China

Contacts

Public ContactWeimin Mao

maowm1218@163.com+86 571-88122032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026